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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulse-generator, pacemaker, external
Regulation Description External pacemaker pulse generator.
Product CodeDTE
Regulation Number 870.3600
Device Class 2


Premarket Reviews
ManufacturerDecision
SHENZHEN LIFETECH CARDIO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLO PACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K241781  Solo Pace Control

MDR Year MDR Reports MDR Events
2021 899 899
2022 833 835
2023 650 651
2024 620 620
2025 643 643
2026 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 611 611
No Display/Image 609 609
Mechanical Problem 591 591
Calibration Problem 376 376
Display or Visual Feedback Problem 346 346
Output Problem 330 330
Device Sensing Problem 237 237
Unexpected Shutdown 216 216
No Device Output 202 202
Use of Device Problem 199 199
Failure to Power Up 197 197
Break 165 166
Material Integrity Problem 135 135
Corroded 115 115
Battery Problem 96 96
Component Missing 87 87
Contamination 81 81
Electrical /Electronic Property Problem 74 74
Failure to Capture 66 66
Crack 55 55
Loose or Intermittent Connection 43 43
Capturing Problem 35 35
Power Problem 33 33
Pacing Problem 24 24
Under-Sensing 20 20
Pacing Intermittently 20 20
Output below Specifications 16 16
Adverse Event Without Identified Device or Use Problem 16 17
Moisture Damage 16 16
Failure to Sense 13 13
Intermittent Capture 12 13
Over-Sensing 9 9
Premature Discharge of Battery 8 8
Output above Specifications 8 8
Failure to Shut Off 8 8
Failure of Device to Self-Test 6 6
Sensing Intermittently 6 6
Failure to Calibrate 6 6
Inadequate User Interface 5 5
Key or Button Unresponsive/not Working 4 4
Operating System Becomes Nonfunctional 4 4
Blocked Connection 4 4
Circuit Failure 4 4
No Pacing 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Device Contamination with Chemical or Other Material 3 3
Insufficient Information 3 3
Device Difficult to Program or Calibrate 3 3
Impedance Problem 3 3
Contamination /Decontamination Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3606 3607
Cardiac Arrest 40 40
Ventricular Fibrillation 31 31
Asystole 31 31
Arrhythmia 24 25
Tachycardia 17 17
Bradycardia 13 13
Heart Block 8 8
Insufficient Information 8 8
Loss of consciousness 7 7
Superficial (First Degree) Burn 6 6
Low Blood Pressure/ Hypotension 5 6
Atrial Flutter 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 4
Erythema 3 3
Non specific EKG/ECG Changes 2 2
Syncope/Fainting 2 2
Diaphoresis 2 2
Low Oxygen Saturation 2 2
Dizziness 2 2
Skin Inflammation/ Irritation 2 2
Aspiration/Inhalation 2 2
Abrasion 2 2
Multiple Organ Failure 2 2
Pericardial Effusion 2 3
Blister 2 2
Unspecified Heart Problem 2 2
Discomfort 2 2
Pneumonia 2 2
Bruise/Contusion 1 1
Respiratory Failure 1 1
Hemorrhage/Bleeding 1 1
Ectopic Heartbeat 1 1
Hypoxia 1 1
Swelling/ Edema 1 1
Sudden Cardiac Death 1 1
Stenosis 1 1
Shock 1 1
Pulmonary Edema 1 1
Dyspnea 1 1
Septic Shock 1 1
Cardiac Perforation 1 1
Pallor 1 1
Burn(s) 1 1
Angina 1 1
Cardiac Tamponade 1 1
Skin Discoloration 1 1
Device Overstimulation of Tissue 1 1
Muscle Weakness 1 1
Perforation 1 2

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